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Last Updated: April 25, 2025

Details for Patent: 9,456,993


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Which drugs does patent 9,456,993 protect, and when does it expire?

Patent 9,456,993 protects XELSTRYM and is included in one NDA.

This patent has eighteen patent family members in ten countries.

Summary for Patent: 9,456,993
Title:Compositions and methods for transdermal delivery of amphetamine
Abstract: Compositions for the transdermal delivery of amphetamine in a flexible, finite form are described. The compositions comprise a polymer matrix that includes amphetamine or a pharmaceutically acceptable salt or prodrug thereof and a backing layer comprising a polyurethane film layer and a polyester film layer, with a polyurethane adhesive disposed therebetween. Related methods also are described. Also described are compositions that exhibit a short onset period and a long duration of therapeutic effect.
Inventor(s): Lambert; Robert L. (Miami, FL)
Assignee: NOVEN PHARMACEUTICALS, INC. (Miami, FL)
Application Number:14/585,964
Patent Claim Types:
see list of patent claims
Use; Composition; Delivery;
Patent landscape, scope, and claims:

United States Patent 9,456,993: A Detailed Analysis of Scope and Claims

Introduction

The United States Patent 9,456,993, titled "Authentication Method," is a patent that has been at the center of significant legal and technical discussions. This patent, held by CosmoKey Solutions GmbH & Co. KG, pertains to an authentication method designed to enhance security and simplicity in user transactions. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background of the Patent

The patent in question describes an authentication method that involves activating an authentication function on a user's mobile device to verify the user's identity during transactions with remote partners, such as banks or secured databases[2].

Claims of the Patent

The claims of the '993 patent are directed towards a specific method of authentication. Here are the key aspects:

  • Activation of Authentication Function: The method involves activating an authentication function on the user's mobile device.
  • User Identity Verification: The process is designed to verify the user's identity to permit access to transactions.
  • Remote Transaction Partners: The authentication is conducted when the user communicates with remote transaction partners, such as banks or secured databases[2].

Patent Eligibility Under Alice

The patent eligibility of the '993 patent has been a subject of controversy. Here’s how it stands under the Alice two-step framework:

Step One: Abstract Idea

The district court initially held that the claims are directed to the abstract idea of authentication, which is a patent-ineligible concept under 35 U.S.C. § 101. This decision was based on the premise that the claims do not recite any patent-eligible inventive concept beyond the abstract idea[2].

Step Two: Inventive Concept

However, the Federal Circuit Court of Appeals reversed this decision, concluding that the claims do provide a specific improvement to a particular computer-implemented authentication technique. This improvement was deemed sufficient to transform the abstract idea into a patent-eligible invention[2].

Technical and Legal Implications

The technical and legal implications of this patent are significant:

Specific Improvement

The patent specifies a method that combines multiple conventional authentication techniques in a novel way, enhancing both security and simplicity. This specific improvement was crucial in establishing the patent's eligibility under Alice step two[2].

Industry Impact

This patent has implications for the broader authentication industry, particularly in the context of mobile device security. It sets a precedent for how authentication methods can be patented and protected, influencing the development of similar technologies.

Patent Scope and Quality

The scope and quality of the '993 patent are also important considerations:

Metrics for Patent Scope

Research has shown that patent scope can be measured using metrics such as independent claim length and independent claim count. These metrics help in assessing the breadth and clarity of patent claims, which are critical for determining patent quality[3].

USPTO Guidelines

The U.S. Patent and Trademark Office (USPTO) has emphasized the importance of clear and concise claim language. The USPTO defines a quality patent as one that is correctly issued in compliance with all statutory requirements and relevant case law. This includes ensuring that the claims are novel, clear, and upheld if challenged[4].

Litigation and Legal Precedents

The '993 patent has been involved in significant litigation:

CosmoKey Solutions GmbH & Co. KG v. Duo Security LLC

In this case, the Federal Circuit Court of Appeals reversed the district court's decision, holding that the claims of the '993 patent are patent-eligible. This ruling set a precedent for how similar authentication patents might be evaluated in the future[2].

Future Implications and Recommendations

Given the complexities surrounding patent eligibility and quality, several recommendations and future implications arise:

Consistent Definition of Patent Quality

The USPTO should continue to define and articulate patent quality consistently in its documents and guidance. This includes ensuring that patents meet statutory requirements for novelty, clarity, and non-obviousness[4].

Claim Clarity Tools

While the USPTO has considered requiring claim clarity tools such as glossaries or claim charts, it has decided against such requirements due to stakeholder feedback. However, the importance of clear and concise claim language remains a critical factor in patent quality[4].

Small Claims Patent Court

The concept of a small claims patent court, currently under study by the Administrative Conference of the United States (ACUS), could provide a more streamlined and cost-effective way to resolve patent disputes, potentially affecting the landscape for patents like the '993 patent[5].

Key Takeaways

  • Patent Eligibility: The '993 patent was deemed patent-eligible under the Alice two-step framework due to its specific improvement to a particular computer-implemented authentication technique.
  • Technical Implications: The patent combines conventional authentication techniques in a novel way, enhancing security and simplicity.
  • Legal Precedents: The litigation surrounding this patent sets a precedent for evaluating similar authentication patents.
  • Patent Quality: The USPTO's guidelines on patent quality emphasize the importance of clear and concise claim language.
  • Future Implications: The study on a small claims patent court could impact how patent disputes are resolved in the future.

FAQs

What is the main subject of the United States Patent 9,456,993?

The main subject of the patent is an authentication method that involves activating an authentication function on a user's mobile device to verify the user's identity during transactions.

Why was the patent initially deemed ineligible under 35 U.S.C. § 101?

The district court initially held that the claims were directed to the abstract idea of authentication without reciting any patent-eligible inventive concept.

How did the Federal Circuit Court of Appeals rule on the patent's eligibility?

The Federal Circuit Court of Appeals reversed the district court's decision, ruling that the claims provide a specific improvement to a particular computer-implemented authentication technique, making them patent-eligible.

What are the implications of this patent for the authentication industry?

The patent sets a precedent for how authentication methods can be patented and protected, influencing the development of similar technologies in the industry.

How does the USPTO define patent quality, and what are the implications for this patent?

The USPTO defines a quality patent as one that is correctly issued in compliance with all statutory requirements and relevant case law. This includes ensuring that the claims are novel, clear, and upheld if challenged, which has implications for the clarity and validity of the '993 patent.

What is the current status of the small claims patent court study, and how might it affect patents like the '993 patent?

The study on a small claims patent court is ongoing, with ACUS engaging stakeholders and gathering feedback. If implemented, it could provide a more streamlined and cost-effective way to resolve patent disputes, potentially affecting the landscape for patents like the '993 patent.

Sources

  1. US9456993B2 - Compositions and methods for transdermal delivery of amphetamine - Google Patents
  2. CosmoKey Solutions GmbH & Co. KG v. Duo Security LLC - CAFC
  3. Patent Claims and Patent Scope - SSRN
  4. Intellectual Property: Patent Office Should Define Quality, Reassess ... - GAO
  5. U.S. Patent Small Claims Court - ACUS

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Drugs Protected by US Patent 9,456,993

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Noven Pharms Inc XELSTRYM dextroamphetamine SYSTEM;TRANSDERMAL 215401-001 Mar 22, 2022 RX Yes No ⤷  Try for Free ⤷  Try for Free Y A METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER BY ADMINISTERING A TRANSDERMAL COMPOSITION CONTAINING AMPHETAMINE ⤷  Try for Free
Noven Pharms Inc XELSTRYM dextroamphetamine SYSTEM;TRANSDERMAL 215401-002 Mar 22, 2022 RX Yes No ⤷  Try for Free ⤷  Try for Free Y A METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER BY ADMINISTERING A TRANSDERMAL COMPOSITION CONTAINING AMPHETAMINE ⤷  Try for Free
Noven Pharms Inc XELSTRYM dextroamphetamine SYSTEM;TRANSDERMAL 215401-003 Mar 22, 2022 RX Yes No ⤷  Try for Free ⤷  Try for Free Y A METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER BY ADMINISTERING A TRANSDERMAL COMPOSITION CONTAINING AMPHETAMINE ⤷  Try for Free
Noven Pharms Inc XELSTRYM dextroamphetamine SYSTEM;TRANSDERMAL 215401-004 Mar 22, 2022 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y A METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER BY ADMINISTERING A TRANSDERMAL COMPOSITION CONTAINING AMPHETAMINE ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 9,456,993

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 093118 ⤷  Try for Free
Argentina 098878 ⤷  Try for Free
Australia 2014370133 ⤷  Try for Free
Canada 2889452 ⤷  Try for Free
Canada 2934924 ⤷  Try for Free
European Patent Office 2934496 ⤷  Try for Free
European Patent Office 3086783 ⤷  Try for Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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